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Sr. Project EngineerK2M

THIS JOB HAS EXPIRED

Plans, directs, and conducts engineering research and development activities on projects of a very sophisticated nature containing technology in the areas of: biomechanics and mechanisms; molded, machined, and sheet metal parts. Supervises engineers, designers, scientists, and technicians; guides and reviews their progress and evaluates / approves the results of their work. Determines resource needs, develops plans, tracks progress to those plans, resolves conflicts and delivers scheduled milestones to projects. Personally contributes to development activity by providing original concept work overall, and performing some detail designs for complex parts of systems and sub-components.

include the following:

Conceive, develop, and launch novel spinal systems in accordance with established policies, goals, and objectives. Manage the development of new products and product concepts using existing and emerging technologies per design control requirements.
Manage a group of R&D mechanical engineers and/or designers
Prepare plans, budgets and schedules for new product development.
Present development progress information to senior staff including: progress towards development schedule, budget considerations, technical or schedule challenges, infrastructure considerations, and new developments.
Contribute to the development and authorization of SOPs, operational procedures, part and assembly drawings, test reports, MRB decisions, financial documents and other related documents.
Participate in and lead, as applicable, design reviews.
Prepare and review information for patent applications.
Perform component and process vendor identification and support.
Manage and approve effort to verify and validate new product designs.
Prepare and manage test protocols and reports.
Support regulatory submissions including 510(k), PMA, and CE mark.
Working with Marketing and directly with customers, help ensure development and testing of prototypes to meet market and customer requirements and make recommendations for potential R&D direction on new efforts.
Maintain sufficient and accurate technical records in an engineering notebook per company policies.
Support material review board and corrective action requirements as they relate to R&D support and personnel.

Bachelor?s degree in Mechanical Engineering from a top engineering school, Master?s degree preferred.

3-4 years program/project management experience, leading mechanically based medical device teams as well as interfacing with multi-disciplinary teams.
Must have experience in a regulated environment with preference given to those working under FDA, GMP compliance guidelines
Must have a proven track record of effective, organized, thoughtful team leadership.
7 ? 10 years engineering experience in the medical device field, involving complex mechanism design
5 plus years in spine
Must have a demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
Must have the ability to professionally and effectively present information to, and receive feedback from staff as well as external partners.
Extensive knowledge of biomechanical design and manufacturing processes in medium to low volume environments.
Clear understanding of quality standards, regulatory pathways, and manufacturing operations and how those departments relate to R&D mechanical engineering.
Experience working with ISO requirements, GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes.
Must have strong analytical and problem solving skills, as well as a good background in the product development process.
Comfortable working with and seeking optimum solutions with mechanical engineering team members, regulatory, clinical, quality, marketing, and manufacturing.
Proven design skills involving complex mechanisms. Track record of rapid product development of concept through launch.
Strong creative ability (as demonstrated by a number of patents) as well as IP knowledge.
Strong working knowledge of GD&T

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